Approval

One essential requirement for operating successfully on any market is to always stay up to date with the latest legal restrictions or necessary certifications for your business segment.

This working group’s main task is to have a close look at the current status quo in order to define what is needed to gain approval for 3D-printed medical devices and to establish them in the industry.

To achieve this, we concentrate on the following topics:

Dr. Cora Lüders-Theuerkauf

Network Manager Medical

Simon Schlagintweit

Medical Expert & Lead Auditor

TÜV Süd Production Service GmbH

Topics

European Medical Device Regulation (MDR): Converting old standards into new standards (norms, liability, certification)

Jointly overcoming regulatory hurdles in the certification process

Leveraging know-how transfer by inviting specialists in MDR, quality management, end-to-end solutions, point-of-care manufacturing, cost management, etc.

3D Systems

BAM

be on quality

Bigrep

Expertants

Formlabs

Fraunhofer ILT

GMH Gruppe

Leupold Legal

materialise

Ottobock

PTB

Siemens

Trumpf

Tüv Süd

More Medical goes Additive Working Groups